NCT05071651

Brief Summary

PRIMARY OBJECTIVE : To evaluate the methods of prevention of the appearance of blisters set up by the runners before and during an ultra-trail SECONDARY OBJECTIVES : To evaluate :

  • The main locations of blisters.
  • The severity of blisters
  • The effectiveness of prevention methods To evaluate the incidence of blisters in an ultra-trail context.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 6, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2021

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 8, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2021

Completed
Last Updated

October 8, 2021

Status Verified

August 1, 2021

Enrollment Period

5 months

First QC Date

August 23, 2021

Last Update Submit

October 7, 2021

Conditions

Sport InjuryBlister of Foot

Outcome Measures

Primary Outcomes (1)

  • Prevention methods used before an ultra-trail via a self-questionnaire

    Prevention methods used before an ultra-trail

    Through study completion, an average of 1 year

Secondary Outcomes (2)

  • Location of blisters, via a self-questionnaire

    Through study completion, an average of 1 year

  • Presence or not of blisters at the end of the ultra-trail or at the time of abandonment

    Through study completion, an average of 1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

ultra runners

You may qualify if:

  • Ultra-trail participants with validated registration

You may not qualify if:

  • Presence of blisters or other skin lesions on the feet before the race

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ifremmont

Chamonix, France

RECRUITING

Study Officials

  • Corentin Tanné, MD

    Institut de Formation et de Recherche en Médecine de Montagne

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Corentin Tanné, MD

CONTACT

0450473105C.Tanne@ch-sallanches-chamonix.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2021

First Posted

October 8, 2021

Study Start

April 6, 2021

Primary Completion

August 31, 2021

Study Completion

December 12, 2021

Last Updated

October 8, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)